genetically modified crops and food...genetically modified (gm) crops are products of the modern...

RESEARCH PAPER 99/3831 MARCH 1999

Genetically ModifiedCrops and Food

This paper gives a brief overview of current issues ingenetically modified crops and food. For crops, itdiscusses the position on field trials and moves towardscommercial development. For food, it provides somebackground to the regulations on the labelling ofgenetically modified food

Christopher Barclay

SCIENCE AND ENVIRONMENT SECTION

HOUSE OF COMMONS LIBRARY

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Summary of main points

• Both GM crops and GM foods are subject to systems of control.• The main arguments for and against GM crops are briefly stated, although not evaluated.• The House of Lords Select Committee on the European Communities recently produced a

favourable report on the EU system of regulation of GM crops.• English Nature criticised that conclusion, arguing that the use of herbicide-tolerant crops

would encourage farmers to use more herbicides and damage wildlife.• The Government has denied newspaper reports that it has agreed a three-year moratorium

on the planting of GM crops.• The Government’s position on GM food is stated.• The Food Labelling (Amendment) Regulations 1999 (SI 747) are explained in the context

of the EU labelling requirements.• The experience of other EU countries and of the USA is briefly explained.

CONTENTS

I Introduction 9

II What scientists can do 10

III Controls over GM crops 11

A. An overview of the system of controls 11

B. The regulatory system announced in October 1998 12

C. Is there to be a moratorium on the planting of GM crops? 15

IV Some Issues relating to GM crops 17

A. Some Concerns about GM crops and some replies 17

B. Field Trials 18

C. Are GM Trials Illegal? 19

V The Report by the House of Lords Select Committee on theEuropean Communities 20

A. The Conclusions of the Report 20

B. The Government’s Response 21

C. English Nature’s Criticism of the House of Lords Report 22

VI Genetically Modified Food 24

A. Introduction 24

B. An overview of the system of controls 25

C. British Government position on GM Food 25

D. The Joint Statement of 18 February 1999 27

VII Labelling 28

A. The background to the March 1999 Regulations 28

B. Comment on the Regulations 30

C. The House of Lords Report comments on food labelling 30

VIII The March 1999 Regulations 33

A. What the Government is trying to do 33

B. The effect of the Regulations 33

IX What other countries are doing 35

A. EU countries 35

B. The USA 37

RESEARCH PAPER 99/38

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I Introduction

The whole topic of genetically modified crops and food has become extremelycontroversial over the past two years, and particularly over the past two months. Thispaper describes the regulatory background, the position of the Government and some ofthe issues raised. It also describes the role of the new regulations on the labelling ofgenetically modified (GM) food. This paper does not attempt to summarise the scientificdebate, let alone judge the conclusions.

There are several reasons for not doing so. First, there are many reports aimed atproviding a summary, including a recent select committee report and a report by theParliamentary Office of Science and Technology in 1998.1 Second, the evidence is basedupon a number of individual studies, particularly for the environmental consequences ofGM crops. Merely reporting the results of the studies in summary form may give adistorted view of the scientific debate. Third, there are some parts of the debate in whichthere is so much controversy about the interpretation of the results that it would beunrealistic for a paper of this type either a take a position or even to summarise theopposing interpretations in a generally acceptable way.

Crops and food are treated separately, because different issues are raised. The use of GMcrops raises environmental questions. It is regulated by the Department of theEnvironment, Transport and the Regions (DETR) and the Health and Safety Executive(HSE), as well as the Ministry of Agriculture, Fisheries and Food (MAFF). The use ofGM food, raises food safety questions and is regulated by MAFF and the Department ofHealth. Two advisory committees are very important. The Advisory Committee onReleases into the Environment (ACRE) advises the Secretary of State for theEnvironment on the release of GMOs. The Advisory Committee on Novel Foods andProcesses (ACNFP) advises on the safety on novel foods, including GM food. In eachcase the secretariat consists of civil servants, but the membership consists of independentexperts. These are mostly scientists in appropriate disciplines, but a few consumerrepresentatives are included. Other advisory committees may also be involved.

1 Select Committee on the European Communities, EC Regulation of Genetic Modification inAgriculture, 15 December 1998, HL 11 1998-99; Parliamentary office of Science and Technology,Genetically Modified Food, May 1998


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II What scientists can do

Genetically modified (GM) crops are products of the modern biotechnology industry, whichhas developed after the discovery of the structure of DNA in 1953 by Crick and Watson.Although, it took some decades for the possibilities to develop into commercial techniques,since the 1970s many new applications have appeared.2

Food has been the product of science for millennia. Processes such as winemaking, brewingor the preserving of foods have involved chemical changes and could be considered foodtechnology. Selective breeding of animals has been undertaken for centuries and systematicselective breeding of farm animals to develop better stock has been operating in the UK forabout two hundred years. Modern food, of course, is partly the result of the application ofmodern science. Crops are grown with the help of fertilisers and pesticides. Additives areused to help preserve the food and to control its taste. Otherwise, it would simply not bepossible to obtain such a wide range of foods, of uniformly good quality, on the supermarketshelves.

The techniques of biotechnology go well beyond that. It is becoming increasingly possibleto identify, within an organism, exactly which gene confers each particular quality and toeither alter that gene, or even transfer that gene to an organism of a different type. Ofcourse, the complexity of life is such that a particular quality is very rarely determined by asingle gene, but there are cases where the transfer or alteration of a single gene can changeparticular qualities, either in a plant or occasionally in an animal.

The term "genetic modification", when applied to food, refers to any artificial alteration inthe genetic makeup of a food, animal or plant, or to the use of genetic engineeringtechniques in the production and manufacturing of food. It therefore covers a whole rangeof techniques.

Once a gene has been altered, or a copy made of all or part of a gene, "copy genes" do nothave to be put back into the same type of animal or plant from which they were extracted.They might originate from one organism and be inserted into another species altogether.This transfer can even take place from an animal to a plant, so that an animal gene is copiedinto a plant, or vice versa. Any animal or plant that carries genes from another species isknown as a "transgenic" organism.3 However, it is very important to note that only copies ofthe information contained within genes are inserted in all cases, the original genesthemselves are not transferred.

Important applications have already been developed. Plants can be genetically modified toconfer resistance against pests or to remain edible longer before becoming mouldy. Suchgenetic modification might reduce the need for pesticides or it might merely benefit theretailer. GM techniques can also be used to manufacture pharmaceuticals.

2 The general issues, and the legislation relating to the release of GM organisms are discussed in more detailin an earlier Library Paper: Genetically Modified Organisms, Transgenic Animals and Animal Patenting,Library Research Paper 93/55

3 For further details, see Library Research Paper 93/55, Genetically Modified Organisms, TransgenicAnimals and Animal Patenting


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III Controls over GM crops

A. An overview of the system of controls

The Government issued a consultation paper in the summer of 1997 on geneticallymodified herbicide tolerant (GMHT) crops,4 which listed the current controls on the useof GMHT crops:

5. The Environmental Protection Act 1990 and the Genetically ModifiedOrganisms (Deliberate Release) Regulations 1990 and 1995 say that, beforeany genetically modified organism (GMO) can be released into theenvironment a consent has to be issued by the Secretary of State for theEnvironment. The UK Agriculture Ministers act jointly with the Secretary ofState in matters in which they have an interest, including all agricultural crops.The Advisory Committee on Releases into the Environment (ACRE) advisesMinisters on applications to release GMOs. Consents may be given to therelease of GMOs for experimental purposes, or for the commercial marketingof a GMO. The UK legislation mentioned above implements an EU Directivecovering the release and marketing of GMOs. Applications to market areconsidered by all Member States, and consents issued which apply across theEU.

6. The aim of these statutory controls is to protect human health and theenvironment, and there is no suggestion that GMHT crops pose any newhazard in these respects. But the controls do not specifically address thepotential disadvantages of GMHT crops for agriculture.

7. Before seed varieties, including GM crops, can be marketed in the UK, theyneed to be listed either on the UK National List or on the EU CommonCatalogue of Varieties. This involves official testing to confirm that the newvariety is distinct from and, in the case of the main agricultural crops, showsreal improvements over existing varieties.

8. Only herbicides approved under the Control of Pesticides Regulations 1986 orthe Plant Protection Products Regulations 1995 may be sold, supplied, stored,advertised or used in the UK. Applicants must demonstrate the efficacy andsafety of their product. Approvals are product specific and most are for use onnamed crops only. If tolerance develops towards particular herbicides, theirapproval may need to be reviewed.

EC proposals to amend Directive 90/220 are currently under discussion.5 The aim of theproposal is to amend the procedures. Risk assessment will have to take into accountdirect and indirect, immediate and delayed, effects of the release of GMOs into theenvironment. The R&D procedures would be changed, removing the possibility ofsimplif ied procedures.

4 MAFF News Release 196/97, Minister seeks public’s views on new genetic crops, 10 July 1997


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The Government’s response in the Explanatory Memorandum is unenthusiastic.

15. The Government’s view is that implementation of the Directive hasproceeded well as regards research releases, but that the procedures forauthorisation of GMO products are not satisfactory, particularly in respect of thetimetable for the approval of products. The Government is primarily concernedhowever that the Directive does not provide the framework necessary to addressthe increasing concerns of the public and industry.

16 Whilst accepting the need for reforming procedures, DETR believe that someamendments to the proposals are necessary in order to ensure that, whilemaintaining the high level of protection of the environment and human health andaddressing public concerns, the Directive meets growing public concernsregarding ethical, environmental and social issues and achieves a moretransparent regulatory regime.

The German Presidency hopes to reach a common position in the June 1999 Council onthe proposal.6

B. The regulatory system announced in October 1998

A modification to the regulatory process was announced on 21 October 1998, in astatement by Environment Minister Michael Meacher to House of Lords SelectCommittee:

I am grateful for the opportunity to make this brief opening statement to highlightthree issues in this fast moving debate on the introduction of genetically modifiedorganisms. Firstly the negotiations on the amendment of Directive 90/220, the UKwelcomed the Commission's proposal, which helps to address some outstandingissues. But we think it can go a little further. Our aim is to strike the right balancebetween protecting the environment and human health on the one hand, and on theother, maintaining the proper degree of certainty needed by business for thedevelopment of new products. I think it right to be cautious at this relatively earlystage of the large scale use of the technology in the environment and to make surethat for every product we have practical evidence on safety before we take a decisionto move to commercialisation.

For these reasons, the UK is seeking to make sure that the scope of the directive andof the environmental risk assessment are well-defined and broad enough to coverindirect as well as direct effects of GMOs. We want to strengthen the links betweenthis directive and EC product legislation, such as the Novel Foods Regulation, and weare strongly promoting the introduction of mandatory monitoring of the effects ofproducts in use following marketing approval. We shall also press for changes toensure that member states views are effectively reflected in any decisions onmarketing of products. This is crucial in making the best possible judgement onsafety and will also help acceptance of the technology. To make the regulatoryprocess predictable, we are asking for sensible, but defined time frames for each of

5 Council Document 6378/98 of 26 February 19986 HC Deb 16 March 1999 c 583W


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the steps in the decision-making process. We have pressed for maximum disclosureof information and supported consideration of ethical issues at the Community level.

There appears to be considerable support for these ideas and we are hopeful thatwhen the amendment finally comes into force, we shall have an improved regulatoryregime. But we must not pin everything on that because it will be a number of yearsbefore the amendment is agreed and comes into force. At the same time we are notdespondent: there is much that we can do now, even within the framework of thepresent Directive, and we are trying to exploit every opportunity for improvedcontrols and debate.

Secondly in addition to the important work on revising the Directive, I have beenconsidering how best to respond to calls from groups such as English Nature for amoratorium on the commercial release of certain GM crops and to the great publicanxiety that surrounds this whole technology. The concerns of English Nature andothers centre on fears that the widespread planting of GM herbicide tolerant cropsmay lead to changes in agricultural practice that will reduce our already decliningbiodiversity. I feel strongly that the commercial use of GM crops in agriculture mustnot put unacceptable pressure on our countryside and wildlife and prejudice our goalof maintaining and where possible enhancing farmland biodiversity.

I am very pleased to be able to announce this morning that we have reachedagreement in principle with the plant breeding industry for a programme of manageddevelopment of herbicide tolerant GM crops whereby the first farm-scale plantingsare strictly limited and monitored for ecological effects along with comparableplantings of conventional crops. This process will be underpinned by the strictguidelines for best practice in using GM crops referred to by Jeff Rooker. The resultsof these farm-scale evaluations will be carefully assessed before moving further. Ifeel it is extremely important that we do not travel further down the road tocommercialisation of GM crops before we have this information. If, during thisprocess, we find evidence of harm then we can take appropriate action.

The industry has also made the important commitment that no insect resistant GMcrops will be introduced into the UK for the next three years. The concept ofmanaged development provides a precautionary way forward to investigate in aproper scientific framework the concerns that some GM crops might be harmful tothe environment.

Thirdly I also welcome the announcement of the new cabinet committee. I amacutely aware of the public unease over genetic modification and the widely heldbelief that these concerns are not being heard or addressed by Government. In myown area of responsibility, I am also aware of the need to look at developments on ageneric level in order to take a more strategic approach and ensure that the widerissues are addressed properly. Many from both sides of the debate have proposed anenvironmental stakeholders forum to discuss and advise on environmental issuesraised by biotechnology. Such a forum might include representatives of everyonewith an interest, such as farmers, plant breeders, conservation bodies and publicinterest groups. This group would work in parallel with ACRE, which would remaina scientifically based committee considering applications to release or marketgenetically modified plants and other organisms on a case by case basis.7

7 Select Committee on the European Communities, EC Regulation of Genetic Modification inAgriculture, 15 December 1998, HL 11 1998-99


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Mr Rooker then added a statement about MAFF’s approach to GM crops.

If I may, Chairman, I should like to make a short statement about MAFF'sapproach to the control of GMOs.

Public health and protection of the environment are this Government's firstpriorities on GMOs. I want to make it clear that we shall apply all the relevantlegislation - that on GM foods and GM crops, where we share responsibility withDH and DETR respectively; plus that on seeds and pesticides, where MAFF takesthe lead, fully and rigorously. Applications relating to GMOs will be dealt withfairly, but they will not be given any preferential treatment.

We need to recognise however that GM crops are now being grown inconsiderable quantities in other countries and that the UK's policy towards theiruse, and that of their products, must be based on a clear analysis of the scientificfacts so that it is capable of being fully defended in international fora.

In addition to the statutory requirements, MAFF has been considering whatfurther safeguards need to be introduced to respond to the concerns thatorganisations and members of the public have expressed about the possibleimpact of GM crops when grown commercially.

I am aware of concerns that herbicide tolerance, which is one of the main traitsbeing engineered into crops for use in the UK, may cause serious problems as aresult of their spreading to neighbouring crops and related wild plants. The bestway to avoid such problems is for extra care to be taken when the crops aregrown on the farm. MAFF has therefore urged the proponents of GM crops todraw up guidelines on their correct use, on proper identification and on fullrecord-keeping. The industry group dealing with this has made a good deal ofprogress which I welcome. But we are pressing them further to implementmeasures to secure compliance with the guidelines. Not until we are fullysatisfied will we give our endorsement to this approach.

There is also concern about the impact on biodiversity of the herbicides whichwould be applied to GM crops. The argument is that their use would interrupt thefood supply chain for insects, small mammals and birds. There are differingviews as to whether there would be environmental advantages or disadvantages inusing a single, broad-spectrum herbicide compared with the current practice ofusing several different products. I have therefore asked the Pesticides SafetyDirectorate to prepare for me a scientific review comparing the likely impact onbiodiversity of current and possible future practice.

Some people have suggested that the level of herbicide usage on herbicidetolerant crops will rise, while others have suggested it will fall. In order that weare properly informed on this point, I have asked that the scientific review shouldinclude an analysis of the likely level of herbicide usage.

A prior review of this kind should be able to make useful forecasts. But there isno substitute for monitoring the actual usage when the crops are eventually


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grown. I am asking my officials to discuss with the industry an enhancement ofthe Pesticide Usage Survey to give us specific information on this point.

I am also ensuring that herbicides to be used on GM herbicide tolerant crops willhave to be specifically re-assessed for this purpose. Their existing approval willnot automatically be transferred to this new use. The assessment will cover theireffect on non-target species.

Last, there is the issue of the long term safety of the products of these crops whenused as foods. All GM foods are rigorously assessed for safety by the AdvisoryCommittee on Novel Foods & Processes, using internationally recognisedprocedures endorsed by the World Health Organisation, before being allowedonto the market. However, the Government is currently looking into thepossibility of going even further by introducing monitoring arrangements capableof picking up any unexpected effects should they emerge in the future. I hope tobe able to make a further announcement about this shortly.

I hope, Chairman, this demonstrates that in MAFF we are not rushing ahead, butthinking ahead on the control of GMOs. Our approach to these matters is ofcourse an integral part of the Government's overall policy towards the use ofbiotechnology and I very much welcome the announcement yesterday of the newcabinet committee, under the chairmanship of my Rt Hon friend Dr Cunningham,to oversee developments in this area. This will enable us to ensure that theGovernment's policies in this complex area continue to develop in a fully co-ordinated way.8

A magazine hostile to genetic modification reported the announcement withoutenthusiasm:

Amidst Europe-wide pressure for a moratorium on commercialisation of geneticallyengineered (GE) crops, the British government has disappointed environmentalists bydelaying full-scale commercialisation by only a single year. Earlier the governmenthad hinted that it was considering a mandatory three-year moratorium. Instead, therewill be “farm scale” trials of herbicide-tolerant crops on an unspecified number offarms next year…The biotechnology industry has also agreed a voluntary three-yeardelay in commercialisation of insect-resistant crops, although none were scheduledfor commercialisation during this period.9

C. Is there to be a moratorium on the planting of GM crops?

There has recently been widespread newspaper speculation that the Government hasagreed with the industry a three-year moratorium on the planting of GM crops. However,no official announcement to this effect has been made, and a reply to a PQ by DrCunningham on 17 March 1999 contained a strong denial.

8 ibid, also DETR News Release 877, Government announces fuller evaluations of growing geneticallymodified crops, 21 October 1998

9 “UK opts for ‘managed introduction’ of GE crops”, GenEthics News, October/November 1998


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My hon. Friend’s question gives me the opportunity to lay another ghost to rest.It is not true that the Government have reached or are seeking any secret dealwith the industries on genetically modified foods or crops.10

The policy, therefore, presumably remains that stated in the information pack given toMembers of Parliament on 18 February 1999.

Shouldn’t the Government introduce a moratorium on genetically-modifiedcrops?No. Those that argue for a moratorium do so because they feel that there isinsufficient information on the environmental impact of genetically-modifiedcrops. We agree that more needs to be learnt in this area, but we do not believethat a fixed period moratorium is the answer. The voluntary arrangements whichthe industry has agreed with us will allow us to monitor carefully larger scalecultivation of these crops. We will only move to full scale cultivation when weare satisfied that we have enough information about the environmental impacts tobe able to make a sound decision.

10 HC Deb 17 March 1999 c 1108


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IV Some Issues relating to GM crops

It is unfortunate that European public interest in GM crops and food began with theimport from the USA of soya and maize in a way that mixed in the GM and normal crops.Consumers were extremely hostile and the public image of GM food has suffered. Manypeople associate GM crops exclusively with US corporations like Monsanto. However,the suitability of GM crops is a completely separate issue, from that, of the merits of largecorporations. Many researchers, not necessarily in large corporations, have beendeveloping GM crops with characteristics aimed at benefiting the consumer, such asstrawberries that will not need to be sprayed so much with herbicides and fruit withimproved taste.

One particular technique is highly controversial, that of the so-called “terminator” seeds.The technique works by attaching a gene called Late Embryogenesis Abundant to a genethat stops germination and inserting this into a seed. When the seed has grown into aplant, the promoter triggers the “terminator” gene, which sterilises the plant’s maturingseeds.11

A. Some Concerns about GM crops and some replies

The following concerns have been raised:

• Cross fertilisation with other plants, perhaps creating herbicide resistant weeds.• Damage to biodiversity through allowing increased herbicide use in farming.• The use of “terminator” seeds would erode the custom of using farm-saved seed and

place farmers, particularly in the Third World, in a weak bargaining position relativeto a few seed companies.

• Predators eating the GM crop might be damaged, something that could have seriousconsequences in the case of benign predators such as ladybirds that eat pests.

• Farmers might choose to use more herbicides because their use would now becompatible with the GM herbicide resistant crops. The effect might be harmful toother plants and wildlife.

Supporters of GM crops have the following replies:

• Cross fertilisation takes place mainly with closely related plants and could beprevented. If it is a major concern, then crops with “terminator” seeds could beplanted, although it would be necessary to check that the hybrid seeds retained the“terminator” property.

• The question of appropriate farming practices could best be approached by a code ofpractice for farmers rather than a ban on the crops. Herbicide resistant crops can be

11 R.Edwards, “Devilish seed: US officials fear a backlash over ‘terminator technology’”, New Scientist,10 October 1998


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developed through conventional technology and no controls apply to them in thatcase.

• Under British law, farmers have the right to use farm-saved seed, but have to pay forso doing, to the company that developed it. Seed companies say that if the farmersbuy GM crops, so as to be sure of a certain property, such as herbicide resistance, thenit makes sense to use fresh seed in which that property can be guaranteed, rather thanfarm-saved seed in which it cannot.

• It would be possible to genetically modify a crop, so that predators were harmed, butthat is something for which tests can be undertaken and it should be possible togenetically modify crops so that predators are not harmed.

B. Field Trials

A reply to a PQ in June 1998 explained the extent of field trials at that stage:

Angela Eagle: Currently there are 64 experimental trials of genetically modifiedcrops in progress covering a total of approximately 841 acres. Of these one site is494 acres, with the remainder consisting of small size plots with an average area ofless than 2 acres. In addition to the sites for experimental releases, there is oneoilseed rape trial for commercial seed production covering 17.5 acres.

The majority of the experimental trials are for oilseed rape (27), sugar beet (16), andpotatoes (14), although GM wheat (3), maize (2), chicory (1) and barley (1) are alsogrown.12

Another reply at this time mentioned the possibility of cross-pollination:

With respect to cross fertilisation, the risk assessment for applications for consent torelease GMOs always considers firstly, the likelihood of gene transfer occurring andsecondly, the consequences of gene transfer for human health or the environment. Incoming to a view on gene transfer we also take into account internationally agreedstandards for seed purity which have been developed over years of plant breedingexperience. These set out required isolation distances to achieve the required level ofseed purity for seed certification.13

The information pack sent to Members of Parliament on 18 February 1999, said that thearea under cultivation for trials of GM crops in the UK in 1999 is expected to beapproximately 300 hectares.

12 HC Deb 8 June 1998 c 418W13 HC Deb 8 June 1998 c 418W


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C. Are GM Trials Illegal?

R v (1) Secretary of State for the Environment (2) Ministry for Agriculture, Fisheries andFood, ex parte Watson (1998) CA 21/7/98

In a hearing, in the Court of Appeal in 1998, an organic farmer challenged the right ofSharpes International Seeds Ltd to undertake a trial of GM seeds in the neighbouringfields. The organic farmer lost his case, but the judges accepted one argument, that theconduct of the field trials was not in accordance with the Seeds (National List ofVarieties) Regulations 1982 as amended. The regulations said that applicants for theproposed listing of a new seed variety had to submit “the results of two replicated trials”,but the Department of the Environment had not been requiring replicated trial resultssince 1995. In this sense, the trials were not covered by the regulations and thereforeillegal. DETR was therefore left with the option of either requiring the results ofreplicated trials or of amending the 1982 regulations. The Minister has since explainedthe reasons why the requirement for replicated trials was dropped.14

Before seed varieties, including GM crops, can be marketed in the UK, they need to be listedeither on the UK National List or on the EU Common Catalogue of Varieties. This involvesofficial testing to confirm that the new variety is distinct from and, in the case of the mainagricultural crops, shows real improvements over existing varieties. The National Listsystem for varieties was established to implement an EC Directive, to establish whetherseeds are distinct, uniform and stable, and have value for cultivation and use (VCU). Thereason why in practice replicated trials had not been required for some years was explainedin a MAFF news release:

The Seeds (National Lists of Varieties) Regulations 1982, as amended, sets out thelegal requirements for addition of a variety to the National List. Regulation 11(3)provides that applicants must submit the results of replicated trials with theirapplications. This provision was first introduced in 1979 when the system wasoverloaded with varieties which had little chance of meeting requirements foraddition to the National List. It was intended to encourage breeders to do their ownpre-entry trials to screen out those varieties unlikely to be successful in full NationalList trials.

Following a review in 1992/93 a streamlined system of VCU trials was introduced,which reduced the burden of the trials system…Once the pressure on the officialtrials system was relieved, the requirement to submit replicated trials had no valuewhatsoever and was not enforced.15

The legal position was rectified by the Seeds (National Lists of Varieties)(Amendment)Regulations 1998 (SI 2726). Details of trial sites are available on the internet athttp://www.shef.ac.uk/ uni/projects/doe/reg98.html

14 HC Deb 29 July 1998 c 353W15 MAFF News Release 394/98, Amendments to the National Seed Lists Regulations, 8 October 1998

http://www.shef.ac.uk/ uni/projects/doe/reg98.html


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V The Report by the House of Lords Select Committee onthe European Communities

A. The Conclusions of the Report

A report by the House of Lords Select Committee on the European Communities hasproduced a favourable report on genetic modification in agriculture.16 The following arethe main conclusions on genetically modified crops.

Potential benefits and risks

172. Biotechnology in general and genetic modification in particular offergreat potential benefits to agriculture, industry, consumers and even to theenvironment. We consider that GM technology may offer much to organicsystems, for example through reduced inputs (paragraphs 65-72, 78).

173. There are potential risks relating to the environment, including theimpact on ecosystems of out-crossing, pest resistance and stress and multipletolerances (paragraphs 73-86).

174. We consider that environmental risks and benefits should be assessed atthe same time (paragraphs 87-88).

Risk assessment

175. The risks involved in genetic modification can, we believe, becontrolled, if a strict risk management process is in place. A clear, coherent set ofprinciples for environmental impact analysis is needed which allows forconsistent interpretation by Member States (paragraphs 89, 92-93).

176. We recommend that risk assessment should include direct, indirect,immediate and delayed effects. The regulatory system should attempt to predictinteractions. A system which attempted to identify an integrated approach wouldbe preferable to what amounts to a first come, first served approach (paragraphs94-95).

177. In assessing risk, we recommend that modified plants and theirmanagement schedules should be compared with the use of a similar non-modified crop and best agricultural practice (paragraph 90).

178. We recommend that there should be triggers other than geneticmodification which bring the assessment and management system into action, asis the case for novel foods. We recommend that, from now on, any crop with

16 Select Committee on the European Communities, EC Regulation of Genetic Modification inAgriculture, 15 December 1998, HL 11 1998-99


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novel traits which may have the potential to impact significantly on theenvironment should be subject to an oversight system (paragraph 91).

179. The knowledge of how a crop grown on farm and commercial scaleswill interact with the environment can only be acquired by growing it on suchscales. Large scale trials are needed. We consider that an outright moratoriumwould be inappropriate (paragraphs 96-99).

Risk management

180. We welcome the ability to set specific conditions for each commercialrelease. We are however concerned that the draft Directive does not envisage anend-point at which the GM crop is considered safe enough to be released into theenvironment without such constraints (though perhaps with certain managementconditions) (paragraphs 100-101, 170).

181. Conditions and regulations should only be imposed where necessary,but must be adhered to when imposed. The general conditions may best beestablished through a (preferably pan-European) government-sponsored code ofpractice. It may be the case in this instance that a voluntary code of practice willnot be sufficient; if so, the code of practice should be backed up by regulation(paragraphs 105-107).

182. Monitoring is not a substitute for risk assessment but can complementit. We consider that those involved should report on any predicted effects whichdo not occur and any unexpected events which do occur. We recommend thatmonitoring (to Community-wide standards) should be performed by anindependent organisation, funded through levies on applicants. There must alsobe a Community-wide audit of enforcement as monitoring standards (in manyfields) have in the past been subject to too great a variation (paragraphs 102-104).

B. The Government’s Response

The Government’s response to the House of Lords Report was announced on 24 March1999:

Food Safety Minister Jeff Rooker today announced the Government response tothe House of Lords Select Committee on the European Communities Report onEC Regulation of Genetic Modification in Agriculture.

In a Parliamentary answer Mr Rooker said:

"The Government has welcomed the Report as making an important contributionto the intense debate on the regulation of GMOs in agriculture through thepresentation of a balanced and considered perspective on the key issuessurrounding the application of biotechnology in agriculture and food production.

"The Government's response in particular welcomes a number of the Committee'srecommendations.


22

"It makes the point that rigorous and wide-ranging assessment of risks to theenvironment and human health must continue to form the foundations of theregulatory process and that the Government is committed to ensuring that riskassessment provisions are strengthened and extended to include indirect anddelayed environmental effects.

"The response also supports the Committee's recommendations on monitoring onthe grounds that this will allow a clear picture to be built up of the environmentaleffects of GMOs, and enable the assumptions in the risk assessment to beverified.

"The response further welcomes the Committee's recommendations on labellingand makes clear that the Government is pressing the European Commission todevelop further proposals on thresholds for adventitious contamination and a listof materials from GM crops that will not require labelling.

"Finally, the response states that the effective and timely revision of Directive90/220 on the deliberate release into the environment of GMOs is a major priorityfor the Government. It offers the opportunity to reinforce the existing legislationto secure full protection for human health and the environment, while providing astable and predictable regime which will maintain UK and EU competitiveness inthe commercial exploitation of biotechnology and genome research.

"The European Parliament adopted its first reading Opinion in February 1999.The Government welcomes the Opinion, and supports the Parliament's call formoves to reach a common position shortly."17

C. English Nature’s Criticism of the House of Lords Report

Responding to the recent report from the Lords Select Committee dealing with GeneticallyModified Crops, English Nature, the Government’s statutory adviser on wildlife and theCountryside, issued the following statement:

It is unfortunate that the presentation of the House of Lords report gave theimpression of unqualified support for the benefits of genetically modified crops.The environmental risks of GMOs to wildlife and the environment have becomeincreasingly accepted both by the regulators and the informed public. Indeedalmost half of the Committee’s recommendations are concerned with broadeningand making more rigorous the risk assessment and regulatory process necessaryto deal with these risks.

English Nature cannot understand how, while stressing the need for considerabletightening of the process of research and appraisal before any release oforganisms was agreed, the overall message from the report can be that GMOsshould go ahead.

17 MAFF News Release 105/99, Government welcomes the House of Lords report on GM crops, 24 March1999


23

We are very disappointed that this Committee appears to have failed tounderstand the implications for farmland wildlife of growing geneticallymodified herbicide tolerant (HT) and insect resistant (IR) crops. They say thatthese crops may benefit wildlife but there is no scientific evidence from Europe,the US and Canada supporting this.

The Committee has completely failed to grasp the point that applying broadspectrum herbicides to HT crops during the growing season will give many morefarmers the power to remove all weeds from fields, putting yet more pressure onour already beleaguered wildlife. We are also concerned that IR crops containinginsecticides may have serious effects on non-target insect populations, reducingstill further the food available to farmland birds.

In the past 20 years populations of 10 farmland bird species such as skylark, cornbunting and grey partridge have crashed to an all-time low and we now havestrong evidence that a major factor in this decline is the increase in the use andeffectiveness of pesticides, including herbicides.18

A further statement from English Nature clarified its position:

Contrary to what has been reported, we are not asking for a moratorium oncommercial release of all genetically modified crops. We consider that there maybe potential in some of this technology for producing more environmentally-friendly crops and better food in the future, but that this needs further research,proper regulation and adequate safeguards in use. We are however veryconcerned about the effects that introducing herbicide tolerant crops would haveon biodiversity. These new varieties give the farmer the ability to eliminatewildlife in crops where they cannot easily do so. This type of geneticmodification will make farming even more intensive and is undesirable in theBritish countryside where farming and wildlife must co-exist…

Our position on the likely effect of herbicide tolerant crops is based on severalpieces of good scientific research which demonstrate that declines in wild plants,insects and birds on agricultural land is partly due to the use of more efficientherbicides. More research on this topic has been commissioned by DETR andMAFF, but will not report until 2003 at the earliest. In the light of this scientificevidence, we were taken aback by the decision of the Advisory Committee onReleases to the Environment last week to approve the release of herbicide tolerantrape.

Our advice to the government has been that herbicide tolerant crops and insectresistant crops, not all GM crops, should not be released commercially until thisresearch has been completed and assessed by the regulatory system.19

18 English Nature Press Release, English Nature criticizes presentation of House of Lords report, 22January 1999

19 Letter from the Chair of English Nature to the Prime Minister, 4 February 1999, Library DepositedPaper 99/157


24

VI Genetically Modified Food

A. Introduction

Genetically Modified food has become a very controversial topic since late 1996, withconcerns about labelling requirements and possible environmental effects. On the wholethe USA sees this as a scientific advance and is going ahead, while the Europeanauthorities are more cautious and a large part of European public opinion seemspositively hostile.

Only a very few foods or ingredients are available in the UK, as the following reply to aPQ in March 1999 shows:

Lord Donoughue: The GM foods and food ingredients currently on sale in theUK were approved on the following dates:

GM tomato puree February 1995

GM soya ingredients February 1995

GM maize ingredients May 1996

The tomato paste has been clearly labelled by the manufacturer since its marketlaunch in February 1996.

An EC regulation requiring all foods containing GM soya or maize ingredients tobe clearly labelled took effect on 1 September 1998. Prior to this the labelling ofthese foods was voluntary but the Government made clear their intention, soonafter coming into office, of pressing for EC legislation to make such labellingcompulsory.20

However, the soya appears in a wide range of processed foodstuffs, so that the consumermay be consuming products deriving from genetic modification already. Such productswould not necessarily contain genetically modified organisms (GMOs), because theprocessing may mean that it is no longer a living organism. An organism is defined as“any biological entity, cellular or non-cellular, with capacity for self-perpetuation andresponse to evolutionary forces; includes plants, animals, fungi, bacteria and viruses”.21

Therefore, a genetically modified tomato would be a GMO. Even though no longer aliving plant, it would retain the capacity for reproduction through its seeds or bypropagation of plant tissue in, for example, a petri dish. On the other hand, processedGM tomato paste would probably not contain a GMO. Indeed, processing may

20 HL Deb 4 March 1999 c 192WA21 MAFF, Report of the Committee on the Ethics of Genetic Modification and Food Use, 1993, p 42


25

completely destroy the genetically modified material, as the Polkinghorne Reportexplains;

2.17 The presence, or absence of functional genetic material is likely to determineattitudes to the acceptability of particular GM foods. Tests have demonstratedthat mild food processing techniques such as making puree or paste from fruit,will have a negligible effect on the state of the DNA. However, subjection tohigh temperatures, for example in making jam from GM strawberries or canningfood, would degrade the DNA into non-functional components.22

B. An overview of the system of controls

In Britain, anyone wanting to produce genetically modified food must:

Notify the Health and Safety Executive (HSE) for approval;

The HSE consults the Advisory Committee on Genetic Modification (ACGM);

The Secretary of State for the Environment must then give approval before theplants can be grown in field trials;

The Department of Environment (DETR) carries out an environmental riskassessment following advice from the Advisory Committee on Releases to theEnvironment (ACRE);

If field trials are successful, the issue is considered by the Advisory Committeeon Novel Foods and Processes (ACNFP);

The ACNFP can also ask for advice from the Food Advisory Committee (FAC),Committee on Toxicity of Chemicals in Food Consumer Products and theEnvironment (COT), Committees on Carcionogenicity and Mutagenicity, and theCommittee on Medical Aspects of Food Policy (COMA);

and

Finally, a marketing consent allowing the product to be sold is only given by theGovernment following another full risk assessment.23

C. British Government position on GM Food

Successive British Governments have taken note of the issue of GM food. As early as1992, the Government appointed a Committee, under the chairmanship of Dr

22 MAFF, Report of the Committee on the Ethics of Genetic Modification and Food Use, 1993, p 723 MAFF News Release 408/98, Food Minister welcomes shopper survey on Genetically Modified Foods,

20 October 1998


26

Polkinghorne, a clergyman and scientist, to investigate the ethics of genetic modificationand the resulting report appeared in 1993.24 The conclusions were accepted and passed onto the Food Advisory Committee, which produced, among other things, guidelines on thelabelling of GM food. The British labelling requirements, and parts of the system ofcontrol, were voluntary, but the Government knew that EU legislation was going to benecessary, so it did not want to introduce its own laws that would have had to be quicklyrepealed. In view of the very small number of crops ready for research, let alonecommercial application, that strategy does not appear to have caused any problems. TheEU legislation (particularly Regulation 258/97) was largely consistent with the Britishsystem.25

The coming of the US GM soya and maize, along with widespread public concern, hasforced the current British Government to consider labelling issues in more detail. Onesign of the Government’s concern about the mixing of GM produce with other producecame with the announcement by the Food Safety Minister in March 1998 of a list of soyabean growers and distributors that can offer smaller retailers and manufacturers suppliesof non-GM soya.26 In a press notice in November 1998, the Food Safety Minister notedpublic concern.

The farming industry and Government must take account of consumer concernson genetically modified foods, Food Safety Minister Jeff Rooker said today.

Tough new measures and additional checks are being introduced on geneticallymodified crops. Already, food with genetically modified ingredients must belabelled to give consumers a choice. And the Government will encourage greateropenness in the way decisions are taken on genetically modified crops and foods.Addressing members of the Women's Farmers Union at their annual generalmeeting today, Mr Rooker said:

"There are concerns about these new crops and foods. We must recognise that,and act on it. Consumers are also customers. It is not in the food industry'sinterests to ignore the concerns of their customers. Farmers are part of thatindustry.

"We must be entirely open with the public and explain where Britain sits in theglobal marketplace for crops, vegetables and fruit; explain the drawbacks and thebenefits of the new technology; and explain the tight regulatory controls we areputting in place to protect consumers."27

24 MAFF, Report of the Committee on the Ethics of Genetic Modification and Food Use, 199325 UK Government Explanatory Memorandum to EC Draft 8050/92 which, after various revisions, became

Regulation 258/9726 MAFF News Release 123/98, Non-Genetically Modified Soya Supplies Available, 30 March 199827 MAFF News Release 434/98, Concerns recognised on GM Foods says Rooker, 5 November 1998


27

He announced new measures taken by the Government, but they relate to crops ratherthan to food.

D. The Joint Statement of 18 February 1999

The joint statement signed by five ministers was sent to all Members of Parliament on 18February 1999. It contained the following passages on GM Food.

5. Only a very few GM food products are currently on sale in this country. Theyare a tomato paste, a type of soya and a type of maize. Although the genetically-modified soya and maize are used in a wide range of processed foods, it is thesame two products that are used in each of these foods. Some cheeses and otherproducts are made using enzymes produced from genetically-modified materialbut the foods themselves do not contain any such material. All of these productshave been through a rigorous assessment procedure by the United Kingdom’sindependent Advisory committee on Novel Foods and Processes (ACNFP).Although the regulatory procedures governing this area are now determined atEU level, this is a relatively recent development…

6. The government’s primary duty is to protect people and the environment. Thatis why we have a comprehensive framework in place to regulate and advise onbiotechnology at EU and national level, and to assess new products rigorouslybefore they are approved for use. We are confident that the GM productscurrently on sale are safe. No new product would be allowed onto the marketunless and until it went through this safety assessment, which is set out in EUlegislation. If our scientifi c assessment raises doubts about a product, we willoppose its approval at EU level.

7. All member states, including the UK, must respect final decisions taken at EUlevel on whether or not to approve a product. Once a food has been granted alicence, it can be marketed in each member state. However, if new informationcomes to light which calls into question the original approval, a member state canhalt the sale of a product while the new information is evaluated.


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VII Labelling

A. The background to the March 1999 Regulations

Until late 1996, there appeared to be reasonable consensus that labelling of all GM foodwas not necessary since the results were mostly indistinguishable from food producedusing conventional techniques. However, the coming of soya and maize from the USA,not only unlabelled but mixed in with conventional crops, has created a hostile consumerand media reaction. There is now a great distance between supporters and critics of GMtechniques. Supporters, including the regulatory authorities in the USA such as the FDA,see GM techniques as a scientific way of achieving either produce that could have beenbred more slowly by conventional methods or improved varieties. US public opiniondoes not apparently see a problem in mixing GM and conventional crops, withoutrequiring any labelling. In Europe, on the other hand, the agreement on labellingrequirements, very much in line with British policy and the independent report of thePolkinghorne Committee in 1993, has not satisfied public opinion.

The European Union (EU) agreed a Regulation on Novel Foods and Novel FoodIngredients, which came into force on 15 May 1997, requiring the labelling of all novelfoods sold to the consumer where they are judged on the basis of a scientific assessmentnot to be equivalent to existing foods.28 Novel foods are also required to be labelled ifthey give rise to health or ethical concerns. In addition, any product containing agenetically modified organism (GMO) has to be labelled. There are also further rulesconcerning the release of GMOs under a separate EC Directive.29 Thus, for example,seed containing a GMO has to be labelled when sold to farmers.

The US imports of GM soya and maize, came before the EU had reached agreement onits labelling rules and they have, therefore, been covered by national legislation, withsome EU countries offering stricter standards than others. There was considerabledisagreement between Member States about the labelling criteria. A CommissionRegulation appeared in September 199730 and agreement was not reached until May1998.31 The Food Safety Minister described the position:32

28 Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, OJ L 43, 14 Februrary1997

29 Commission Directive 97/35/EC of 18 June 1997 adapting to technical progress for the second timeCouncil Directive 90/220/EEC on the deliberate release into the environment of genetically modifiedorganisms, OJ L 169, 27 June 1997

30 Commission Regulation (EC) No 1813/97 of 19 September 1997 concerning the compulsory labellingof certain foodstuffs produced from genetically modified organisms of particulars other than thoseprovided for in Directive 79/112/EEC, OJ L 257, 20 September 1997

31 Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of thelabelling of certain foodstuffs produced from genetically modified organisms of particulars other thanthose provided or in Directive 79/112/EEC OJ L 159, 3 June 1998

32 HC Deb 8 June 1998 c.453W


29

Mr Rooker: The labelling rules in the Novel Foods and Novel Food IngredientsRegulation (258/97) apply to all foods and food ingredients covered by the regulationincluding those considered under the simplified criteria on the grounds of substantialequivalence. There are no plans to review this regulation at this time. However, lastmonth detailed rules for labelling of genetically modified (GM) soya and maizeingredients were agreed which require all foods to be labelled where any materialarising from the genetic modification process is present. These rules are expected toset a precedent for the way all future GM foods will be required to be labelled inEurope.

The rules to which reference is made are the Food Labelling (Amendment) Regulations1999 (SI 747), which were laid before parliament on 18 March 1999 and came into forceon 19 March 1999. The labelling requirements will apply from 19 September 1999.

In reply to a PQ, Mr Rooker said that food with genetically modified additives shouldalso be labelled, but that further EU legislation would be required.33 A reply to anotherPQ in November 1998 shows the position on other labelling issues still not resolved:

Ms Shipley: I thank my hon. Friend for his reply and for his extensive written replies tomy constituents, many of whom, along with many organisations in Stourbridge, havewritten to me on the subject.

Is there not a problem in that the EU thresholds for GM ingredients have not yet beenagreed, and the labelling regulations which came into force on 1 September do notinclude ingredients which are part of the manufacturing and refining processes?

Mr. Rooker: I agree with my hon. Friend. The rules that came into force on 1September apply to the ingredients in the food purchased by the consumer; they do notaffect the manufacturing process where GM materials may have been used but are nolonger part of the ingredients.

We are negotiating on the important issue of tolerance levels. The new rules do notapply to additives and flavourings. We think that they should and we are pursuingthat in Brussels. It is important to have tolerance levels for GM produce. At a publicmeeting recently I learned that some manufacturers have commercial contracts forbuying and selling foods to each other where tolerance levels of 0.1 to 1 per cent. areallowed for GM produce in allegedly non-GM foods.34

One complication is, that it has not been possible to test reliably for small quantities ofGM material. If testing is not possible, then the food retailer or caterer can only rely uponhis supplier, as being one whose policy on GM crops is known. However, testingtechniques are improving and offer the prospect of accurate testing for very smallquantities of GM material. A report of a new technique developed RHM technology,whose managing director is Bob Marsh, shows the position at the moment.

33 HC Deb 17 December 1998 c 108034 HC Deb 12 November 1998 cc 470-471


30

RHM technology of High Wycombe, Buckinghamshire, says it now has a testthat detects traces of GM ingredients even in heavily processed products, such asthose containing soya oil or lecithins…The test is also the first to measureaccurately what percentage off an ingredient is genetically engineered, claimsMarsh. That could be important for food inspection agencies. The EU isexpected to introduce rules which allow food to be labelled GM-free is less than,say, 2% of the soya or maize within the product is genetically engineered. Thiswill prevent companies being penalised for accidental contamination.35

B. Comment on the Regulations

It is too early for the catering industry to see how the regulations will work, but theChartered Institute of Environmental Health (CIEH) has already raised concerns.

The Institute of Trading Standards Administration (ITSA), in a view shared bythe CIEH, warned that pizzas containing GM tomato puree, and foods with onlytrace elements of GM soya or maize, would not have to be declared. ITSAspokesperson Steve Butterworth said: “The regulations need to be extended to allingredients and the Government needs to establish a definition of ‘GM-free’.Unless this is sorted out, the situation is likely to unravel, confusing theconsumers and undermining the value of food labelling laws.”36

To some extent the appropriate labelling requirements depend on the reason for labelling.Normal labelling of contents can ignore very small quantities, if the concern is forexample, avoiding excess fat intake. Labelling to avoid allergic attacks from consumingminute traces of peanuts cannot use the same cut-off criteria. The appropriate labellingrequirement for GM food cannot be separated from a general view of the reason whylabelling is necessary.

C. The House of Lords Report comments on food labelling

The report by the House of Lords Select Committee on the European Communities, towhich reference has already been made, included the following conclusions on GM food,basically favourable but calling for tighter labelling requirements.

GM food

183. We consider the regulatory process for assessing the safety of novelfoods to be thorough and proper and we see no reason to doubt the safety of foodswhich have been approved by the regulatory process. The emphasis should notbe on "genetically modified" but on the new characteristics of any individualproduct (paragraphs 109-116).

35 A.Coghlan, “Freeze! Gene Police!” New Scientist, 27 March 1999 p 436 W.Hatchett, “New doubts on GM labelling”, Environmental Health News, 26 March 1999, p 2


31

184. Antibiotic-resistant marker genes should be phased out as swiftly aspossible. Research needs to be conducted into how best to consider applicationsinvolving genes without proven track records of food use. We support the callfor the accumulation and sharing of national data to assist regulators (paragraphs75, 109-116).

185. Internal work at MAFF to prepare for the Food Standards Agency ispoor substitute for its launch. We would be encouraged if legislation were to bebrought forward in this Session (paragraphs 118-122).

186. Genetic modification does not concern a single product or variety butwill soon affect the whole spectrum of agriculture. To require traceability for allagricultural commodities would be an exceedingly costly exercise for littlebenefit, especially when there is no anticipated risk to human health (paragraph117).

Consumer choice

187. Once the regulatory process has ensured safety, the success or failureof the technology must be left to consumer choice in the marketplace. The twoissues involved in providing choice are the supply of GM and non-GM productsand labelling (paragraph 128).

188. Segregation must be driven by the market and not required byGovernment. Producers and manufacturers should however be under no illusionas to the climate of consumer opinion in Europe and it would be advisable for theimmediate future for segregation to occur to facilitate consumer choice. Theidentity preservation system is to be commended. The crop and product must stillbe subject to the standard testing and labelling regimes as GM material has oftenbeen found in supposedly unmodified shipments (paragraphs 129-134).

189. We welcome the requirement for the explicit labelling of GM productsin order to help provide consumer choice. We agree with the Commission andGovernment that only products where the transgene or its product are detectableshould be labelled. To demand labelling where such detection is impossiblewould be meaningless. A Community list of products which do not requirelabelling is urgently required (paragraphs 135-139, 145).

190. Any ingredient or additive to a product should be identified as GMwhen the presence of GM material can be detected above an establishedthreshold. No labelling should be required below the threshold. Additionally, ifa finished product contains GM material above a threshold the product itselfshould be labelled.

191. The absence of a testing and thresholds policy is a serious gap incurrent European and domestic legislation. Until a Community policy is agreedwe recommend that MAFF should issue interim guidelines. A workable butcautious threshold for GM presence would perhaps be 2 per cent. (paragraphs136-139, 141-144).


32

192. Information supplementary to that provided on the label of GM foodsmust be available to the consumer. We recommend that Member Stategovernments co-ordinate (but not necessarily be responsible for) theestablishment within each State of a source of information regarding GM foods,to which the consumer may resort for information not provided on the productlabel. In the United Kingdom, this should as soon as possible fall under the remitof the proposed Food Standards Agency (paragraph 140).37

37 Select Committee on the European Communities, Second Report, EC Regulation of GeneticModification in Agriculture, 21 January 1999, HL 11, 1998-99


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VIII The March 1999 Regulations

A. What the Government is trying to do

The News Release announcing the policy described its objectives:

Food Safety Minister Jeff Rooker today announced the introduction of newpowers aimed at enforcing an EC Regulation on the labelling of foodstuffscontaining genetically modified soya or maize.

And in a move in which the UK leads the way in Europe, the controls will alsoapply to restaurants, cafes, bakers and delicatessens. The new measures meanthat outlets selling foods containing GM material that is not properly labelledmay be prosecuted and fined up to £5,000.

In a Parliamentary answer Mr Rooker said:

"I have laid before Parliament this morning the Food Labelling (Amendment)Regulations 1999, which will come into force tomorrow. These provide themeans for Local Authorities to be able to enforce the EC Regulation that requiresall foods containing genetically modified soya or maize ingredients to be clearlylabelled. This Regulation, which took effect last September, applies to all foodsproduced and labelled from that date.

"The Government is determined that consumers should be able to choose whetheror not to eat genetically modified foods. This includes foods sold in restaurants,cafes and takeaways and not just that available from supermarkets. The UK isthe first member state in Europe to take steps to ensure that consumers eating outwill have the same right to choose whether or not to consume foods containingGM ingredients as those buying from shops.

"As a measure of how seriously the Government takes the right of consumers tohave clear, reliable information about the GM content of the food they buy wehave decided not to wait the customary 21 days for these Regulations to comeinto force but to make them fully effective from tomorrow."38

B. The effect of the Regulations

The EC Regulation 258/97, covering the approval of new GM products required that theybe labelled, if the food or ingredients, were no longer equivalent to existing foods oringredients (Article 8). However, it did not explain exactly when labelling was requirednor did it deal with catering. The EC Regulation 1139/98, covering labelling of the soyaand maize that had been approved before 258/97 came into force, made it clear thatlabelling would only be required when DNA or proteins resulting from genetic

38 MAFF News Release 95/99, GM Labelling – Rooker puts new powers on the menu, 18 March 1999


34

modification were present. Paragraphs 16 to 18 of the preamble deal with this importantpoint.

(16) Whereas food and food ingredients produced from genetically modified soyabeans (Glycine max L.) or from genetically modified maize (Zea mays L.), inwhich DNA resulting from genetic modification is present, are not equivalent andshould therefore be subject to labelling requirements;

(17) Whereas it is possible that protein or DNA resulting from geneticmodification has been destroyed by successive stages of processing; whereas, inthat case, foods and food ingredients should be considered equivalent forlabelling purposes; whereas they should therefore not be subject to labellingrequirements; whereas a list of such products should be drawn up;

(18) Whereas, nevertheless, some processing methods may eliminate proteins;whereas the possibility cannot be excluded that such methods may be capable ofbeing applied to food uses; whereas foods and food ingredients in which DNAresulting from genetic modification is not present but in which proteins resultingfrom genetic modification are present, cannot be considered to be equivalent;whereas, therefore, they should be subject to labelling requirements.

As well as providing for the enforcement of the EC Regulations 1139/98, the 1999Regulations extend their provisions to unwrapped food and catering establishments. Insuch cases it is not necessary to label with the GMO particulars. Article 7 forming a newArticle 4B of the 1996 Regulations, requires that:

Alternative particulars are displayed…if there appears on a menu, notice, ticketor label which is readily discernible by an intending purchaser and which islocated at the place at the premises where he chooses that food, indications to theeffect that some of the food sold at those premises contains ingredients producedfrom genetically modified soya beans or maize, or both, as the case may be, andthat further information is available from the staff.

At first sight, it looks as if a stricter regime is being imposed upon the soya and maizethan upon those GM foods approved under Regulation 258/97, but that is slightlymisleading. As noted above, only three foods or food ingredients have been approved inthe UK, two of which are the soya and maize. The third is the tomato paste, which wasapproved under the pre-1997 voluntary system of labelling. This has been approved forparticular containers and sale by a supermarket. It would be legally possible for a catererto buy it and use it in food, but not to provide this information to consumers. However,MAFF does not consider this a likely possibility. Future approvals of GM food willinclude labelling/information requirement that will include the provision of information incatering, modelled on the system in the regulations.


35

IX What other countries are doing

A. EU countries

It is obvious that the regulation of GM food should be done on at least a Europe-widebasis because of the free trade in food. For crops, also the logic of the single market isthat the same rules should apply throughout the Union. If food is approved under theterms of Council Regulation 258/97, then it can be sold throughout the Union. If a GMcrop has been given consent for the deliberate release of genetically modified organisms,then that consent also applies throughout the Union, subject to a qualification explainedbelow. Evidence by MAFF Officials to the House of Lords Select Committee explainedthe thinking.

Since trial releases of GMOs are carried out in defined locations, it is appropriatethat decisions about such releases are taken at national level, with some form ofinformation exchange with other Member States. The marketing of GMOproducts however, presents a different scenario in which an approved product canbe used anywhere in the EC. It is therefore appropriate in this case that decisionsare taken collectively by the competent authorities using a procedure whichallows each competent authority to review and reach a judgement on a marketingapplication in the light of its particular environment. Any procedure whichremoved this possibility would not give due attention to the property thatorganisms, unlike chemicals, are likely to behave differently in differentenvironments.39

Article 16 of Directive 90/220 lays down the criteria by which a Member State candisallow the use of a seed that has been approved at EU level.

1 Where a Member State has justifiable reasons to consider that a product which has beenproperly notified and has received written consent under this Directive constitutes a riskto human health ot the environment, it may provisionally restrict or prohibit the useand/or sale of that product on its territory. It shall immediately inform the Commissionand the other Member State of such action and give reasons for its decision.

2 A decision shall be taken on the matter within three months in accordance with theprocedure laid down in Article 21.

There is a further final stage before a seed can be sold to and planted by farmers. In theUK such a seed needs to be on the national list. The testing for the national list, run byMAFF, checks for agronomic properties such as yield, checks that it is a distinct variety,that it is reasonably resistant to disease, has the properties claimed for it and so on. Itdoes not include environmental checks. The UK could, therefore, ban an individual typeof seed on environmental or health grounds under Article 16. It could also refuse to put aseed on the national list if it failed the necessary tests for efficiency. What it could not

39 Select Committee on the European Communities, Second Report, EC Regulation of GeneticModification in Agriculture, 21 January 1999, HL 11, 1998-99, written evidence, 15 July 1998


36

do, in terms of either EU or British law, would be to ban all GM seeds, regardless of theirproperties.

In practice, however, several countries have introduced unilateral measures to ban seedsapproved at EU level. The measures have been challenged by the European Commissionand may end in cases at the European Court of Justice.

GM Bt-resistant maize, produced by Novartis, was approved by the EU in December1995. Apparently, the maize is unsuitable for planting in the UK, so the question ofinclusion in the UK National List has not arisen. Several countries refused to accept thismaize. Luxembourg and Austria banned the sale or planting of the Bt maize, while Italyand France banned their farmers from planting the modified seed. Luxembourg andAustria are likely to be taken to the European Court of Justice, but the ban has not yetbeen removed.

The French Government suspended its planting approval for three varieties of Novartismaize containing the Bt gene in September 1998, following a Court action brought byGreenpeace in France. The French Court backed the Greenpeace claim that the product’ssubmission for approval to the national register was incomplete and lacked informationon antibiotic resistance that might be caused by planting the crop.40 In December 1998,the Conseil d’Etat, France’s highest administrative court upheld this decision, pending aruling from the European Court of Justice. The objection appears to be because ofprocedural irregularities, rather than on safety grounds.41 The Conseil d’Etat has referredto the European Court of Justice the interpretation of Directive 90/220 because of theoverlapping procedures and decisions appropriate to national authorities or to Communityauthorities.42

The European Commission has decided to make an application to the European Court ofJustice against Portugal for non-respect of Directives 90/220 and 90/219 relating toGMOs. In the case of Belgium, the Commission has sent a formal letter on a ruling bythe European Court of Justice in July 1998 on the country’s failure to adopt and notifynational measures for transposing Directive 90/220. Further applications are being madeagainst Greece and Portugal for failing to adopt national measures and notify theCommission of national measures for adopting Directive 97/35 (the second adaptation totechnical progress of Directive 90/220.43

In other words, the legal position within the European Union is confusing. Severalcountries have delayed implementing EU legislation, while others fact legal challengesfor having done so. The delays partly reflect the new technology and the difficulty of

40 “France suspends GM maize authorisation”, Agra Europe, 2 October 1998, EP/741 “France upholds ban on Novartis maize”, Reuter News Service, 11 December 199842 “France asks EU Court to interpret GMO Directive”, Europe Environment, 8 January 1999, p 143 “Serial infringements”, Europe Environment, 8 January 1999, p 1


37

drafting laws in this area. However, there does appear to be so much hostility towardsGM crops and food in public opinion that some governments are reluctant to implementlaws allowing the use of the techniques.

B. The USA

The USA is the country that has made most advance in the growing of GM crops and inthe approval of GM food. More than 25 agricultural biotechnology products havesuccessfully progressed through the US regulatory system to commercialisation in themarketplace since 1990. Food is regulated by the Food and Drug Administration (FDA),pesticides regulated by the Environmental Protection Agency and plant pests by the USDepartment of Agriculture. Evidence to the House of Lords Select Committee on theEuropean Communities from Mr Timothy Galvin of the US Department of Agriculturestressed the public approval of the US regulatory system, which was understood as beingstable and predictable.

Chairman

378. Is the situation in the US fairly stable? There is no pressure to change theregulatory system in any way to take into account considerations that hithertohave not been taken into account?

A. More recently, there was a request by some consumer groups for the labellingof these products. There are some in the US who believe that we should do moreto regulate these products or label them, but they tend to represent a minority.The overwhelming majority of the public accepts the procedures that we have inplace. Part of the reason for that is that from the very start our process involved aperiod of public comment and review. Even to this day as specific products arereviewed and approved they are noted in our federal register so that there is anawareness on the part of those following this issue as to exactly what steps thefederal agencies have taken to approve these products.

Lord Redesdale

379. You referred to labelling. In supermarkets in the United Kingdom everygenetically modified product is labelled. Are you saying that in the US someproducts are not labelled as such?

A. That is correct.

380. Consumers are not aware that they are eating genetically modified products?

A. Not in each and every case, but they are aware that these products have beenapproved and are available in the marketplace.

The Committee returned to the topic in more detail a few questions later:

Lord Rathcavan

387. Could you deal in more detail with your labelling philosophy? The FDAstate that the "Food, Drug and Cosmetic Act does not require disclosure inlabelling of information solely on the basis of consumer desire to know." Do you


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consider that the consumer has the right to know? Perhaps you can illustrate thisto us? I am not familiar with the practical example in the US of, say, how tomatopaste is labelled if it is a 100 per cent GM product. In the case of certain productsof which soya is a material ingredient, such as a pizza, does that also involveparticular labelling?

A. First, perhaps I may explain the general policy that underlies the labellingrequirements in the US. Labelling policy falls under the Federal Food, Drug andCosmetic Act. Essentially, it requires that the labelling of products should betruthful and not misleading and it should include the common or usual name ofthe food. Perhaps more importantly, it requires labelling only if the end productis materially different in some respect. Our FDA has concluded after a carefulreview that inherently there is nothing in these genetically modified products thatmakes them materially different from their conventional counterparts. Therefore,we do not as a general matter of policy require that these products be labelled. Ifhowever, in future there is a particular genetically modified product that ismaterially different from its conventional counterpart, it has to be labelled. Twospecific examples: Our FDA has required that oil derived from geneticallyengineered canola plants that have high levels of laurate be labelled as "highlaurate canola oil", and that oil from soybean plants modified to express higholeic acid content be labelled as "high oleic soybean oil". Both of these productsare significantly different in composition and use than the conventional products.However, in neither case was the product label required to state that the oil wasproduced through genetic modification. Similar labelling requirements wereimposed on specific sunflower and safflower varieties, even though thosevarieties were developed through conventional mutagenesis.

388. You do not label GM tomato paste?

A. It is just tomato paste. That is because the FDA has reviewed the product andconcluded that the genetically modified version is not materially different fromthe conventional product.

Chairman

389. It is for the FDA to decide whether or not labelling is required?

A. Correct.

390. If, for example, an anti-freeze gene from a flounder or other fish is insertedinto a plant would labelling be required?

A. That could be an example, but I would have to address that question to ourFDA.

391. If there were a modification that reduced or increased fat content would thatrequire labelling?

A. That sort of information is disclosed on the so-called nutritional panel on theside of the label. That covers fat and protein content but there is no specificmention of the fact that the product is genetically modified.


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Lord Rathcavan

392. To return to the tomato paste, from our observation it is a different productcompared to standard tomato paste. Although your FDA may say that it does notrequire labelling, in practice do manufacturers of that product choose to identifyit as a different product—as a GM paste?

A. Our companies do not voluntarily disclose the fact that it is geneticallymodified. They are free to do that. We would support that sort of voluntarydisclosure, but that is not something that the companies have chosen to do.However, if it is a flavour savour tomato, for example, they will sell that productwith that sort of advertising so that people know it is a special tomato which ismore shelf stable and so on. They do other things to advertise the fact that thistomato has special characteristics.

393. It is identified as a different product, not as a genetically modified product?

A. Correct.

Lord Redesdale

394. Is that because such labelling would be detrimental to the sale of thatproduct?

A. I do not know. You would have to put that question to the manufacturers. Forwhatever reason, they have not chosen to put that on the label. It is likely thatthey would do so if they thought there was great consumer concern in the USabout whether or not the product had been genetically modified.

395. Has there been any campaigning against supermarkets who sell unlabelledgenetically modified products?

A. There have been some but it is only a distinct minority who are in favour ofthis kind of labelling.

Lord Willoughby de Broke

396. Are there any consumer organisations represented on the regulatory agencies- the FDA, EPA and Food and Drug Administration - who monitor GMorganisms?

A. No. The agencies are wholly comprised of government officials. We havescientific advisory committees. I do not have a list of their membership. I wouldbe happy to provide that information for the record. It may be that some of theconsumer groups have representatives on those committees. But the consumergroups are free to comment at various stages, even at the stage of developingregulations or as public notice is given that various products are approved or areabout to be approved.

Chairman

397. Is it your view that a labelling requirement can constitute a barrier to trade?

A. It could depending on how it is constructed. For example, on the basis of thenew labelling policy that has been issued by the EU it is not clear to us at this


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point what level of testing may be required. If the US sent a shipload of soybeansto Europe would each bin or hold of the ship have to be sampled individually orwould there be one sample for the whole ship? It is not clear how intensive thatsampling has to be, or what sampling methods will be sanctioned. Until all sortsof operational details are worked out we have concerns that this policy mayconstitute a barrier to trade.

Lord Willoughby de Broke

398. This brings us to the question of segregation. Our impression is that the USis opposed to segregation. Is that correct, or do you accept that segregationshould be decided by consumer choice? Has the US Government made anyattempt to prevent segregation either at home or abroad?

A. What we are opposed to in the US is mandatory segregation. We have notmade any attempt to discourage segregation to the extent that if a seller wantsvoluntarily to segregate a commodity we are not opposed to it. If a seller can finda certain market niche by advertising a product as GMO-free or whatever he isfree to do that. We would support that as a voluntary measure. But in the case ofmandatory segregation the issue for us is whether or not the end product ismaterially different. We have reviewed that issue very carefully in the US andhave concluded that these products are not materially different from theirconventional counterparts. We do not believe therefore that segregation isnecessary. We also believe that on a broad scale segregation is impractical giventhe way that major commodities are produced in the US. Typically, our farmersharvest all their corn or soybeans together, put them in the same bins and movethem to the same terminal elevators. It would be difficult and more costly iffarmers segregated products according to whether or not they were conventionalor genetically modified. However, increased segregation is occurring in the USbut not as a result of whether or not the products are genetically modified; rather,it occurs because today farmers are more interested in producing certaincommodities with special characteristics. In the case of corn, farmers areproducing more higher oil, waxy or white corn that meet specific end-userrequirements. That corn is then segregated and identity preserved in themarketplace. But typically it also commands a premium in the marketplacebecause it offers special characteristics. If a farmer is offered that premium forproducing a different product then he is happy to segregate and give it the specialhandling and attention that it requires.44

44 Select Committee on the European Communities, Second Report, EC Regulation of GeneticModification in Agriculture, 21 January 1999, HL 11, 1998-99, Evidence of 8 July 1998

genetically modified crops and food...genetically modified (gm) crops are products of the modern...

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